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Tight Glycemic Control With Intensive Insulin Therapy in PICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214916
Recruitment Status : Unknown
Verified January 2019 by Greet Van den Berghe, KU Leuven.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : January 30, 2019
Information provided by (Responsible Party):
Greet Van den Berghe, KU Leuven

Brief Summary:
In a previous study, the investigators showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality in adult intensive care patients. Whether this intervention also improves prognosis of pediatric intensive care patients remains unknown. The current prospective, randomized, controlled study will asses the impact of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. On admission patients will be randomly assigned to either strict normalization of blood glucose according age adjusted values or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between 180-200 mg/dl.

Condition or disease Intervention/treatment Phase
Critical Illness Drug: intensive insulin therapy (Actrapid IV to normoglycemia) Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia) Phase 2

Detailed Description:

Study type: Interventional study

Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients
Study Start Date : October 2004
Actual Primary Completion Date : February 2008
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
conventional insulin therapy (using Actrapid IV)
Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)
Other Name: Actrapid IV only for excessive hyperglycemia

Experimental: B
intensive insulin therapy (using actrapid IV)
Drug: intensive insulin therapy (Actrapid IV to normoglycemia)
intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)
Other Name: Actrapid IV to normoglycemia

Primary Outcome Measures :
  1. Reduction of inflammation [ Time Frame: during ICU stay to day 5 ]
  2. duration of dependency on intensive care (days in ICU) [ Time Frame: time in ICU ]

Secondary Outcome Measures :
  1. Duration mechanical ventilation [ Time Frame: during time in ICU ]
  2. Organ failure/need for organ support [ Time Frame: during time in ICU ]
  3. mortality (safety endpoint) [ Time Frame: during time in ICU ]
  4. long-term follow-up study : focus on neurocognitive development (ethical approval granted) [ Time Frame: 3 years (+/- 6 months) after randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children admitted to the pediatric intensive care unit and anticipated to require intensive care for at least 24 hours

Exclusion Criteria:

  • Expected stay < 24 hours
  • Therapy restriction upon admission
  • No informed consent
  • Other study enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214916

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Dep Intensive Care Medicine University Hospital Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Greet Van den Berghe
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Study Director: Greet Van den Berghe, MD,PhD Catholic University Leuven
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Greet Van den Berghe, Head of Dept and laboratory of Intensive Care Medicine, KU Leuven Identifier: NCT00214916    
Other Study ID Numbers: PICU-insulin study
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Keywords provided by Greet Van den Berghe, KU Leuven:
Tight glycemic control with
intensive insulin treatment
versus conventional glycemic control
in infant or child in ICU
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs